🇺🇸 Miplyffa in United States

FDA authorised Miplyffa on 20 September 2024

Marketing authorisations

FDA — authorised 20 September 2024

Application: NDA214927
Marketing authorisation holder: ZEVRA DENMARK
Local brand name: MIPLYFFA
Indication: CAPSULE — ORAL
Status: approved

The FDA approved Miplyffa, a new molecular entity, on 20 September 2024, under standard expedited pathway. The marketing authorisation holder is ZEVRA DENMARK. The indication approved for Miplyffa is Type 1, which is a new molecular entity. This approval allows ZEVRA DENMARK to market Miplyffa in the United States.

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FDA

Marketing authorisation holder: ZEVRA DENMARK
Status: approved

Miplyffa in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Miplyffa approved in United States?

Yes. FDA authorised it on 20 September 2024; FDA has authorised it.

Who is the marketing authorisation holder for Miplyffa in United States?

ZEVRA DENMARK holds the US marketing authorisation.